Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Waldenstrom's Macroglobulinemia
Waldenstrom Macroglobulinemia
About this trial
This is an interventional treatment trial for Waldenstrom Macroglobulinemia focused on measuring Waldenstrom Macroglobulinemia Recurrent, Waldenstrom Macroglobulinemia Refractory
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed recurrent or progressive Waldenstrom's macroglobulinemia that is unlikely to respond to existing therapy, including surgery, radiotherapy, and chemotherapy Evidence of tumor by MRI, CT scan, chest x-ray, or radionuclide scan Must have received and failed at least one standard first-line therapy (e.g., corticosteroid/alkylator combination) Biochemical evidence of Waldenstrom's macroglobulinemia Abnormal proteins in serum and urine PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: At least 2 months Hematopoietic: WBC at least 2000/mm3 Platelet count at least 50,000/mm3 Hepatic: No hepatic insufficiency Bilirubin no greater than 2.5 mg/dL SGOT and SGPT no greater than 5 times upper limit of normal Renal: No renal insufficiency Creatinine no greater than 2.5 mg/dL No history of renal conditions that contraindicate high dosages of sodium Cardiovascular: No uncontrolled hypertension No history of congestive heart failure No history of other cardiovascular conditions that contraindicate high dosages of sodium Pulmonary: No serious lung disease, such as chronic obstructive pulmonary disease Other: Not pregnant or nursing Fertile patients must use effective contraception during and for 4 weeks after study No active infection No non-malignant systemic disease Not a high medical or psychiatric risk PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy No concurrent immunomodulating agent Chemotherapy: See Disease Characteristics At least 4 weeks (6 weeks since nitrosoureas) since prior chemotherapy No concurrent antineoplastic agents Endocrine therapy: See Disease Characteristics Concurrent corticosteroids allowed Radiotherapy: See Disease Characteristics At least 8 weeks since prior radiotherapy Surgery: See Disease Characteristics Recovered from prior surgery Other: No prior antineoplastons Prior cytodifferentiating agents allowed
Sites / Locations
- Burzynski Clinic
Arms of the Study
Arm 1
Experimental
Antineoplaston therapy
Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.